Materials Matter: Ensuring Quality Of CGT Materials

Cell and gene therapies are only as strong as the materials behind them; from plasmids and viral vectors to cytokines and other critical components, subtle quality issues can quietly derail promising programs. In this Cell & Gene Live, Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, joined Cell & Gene Chief Editor Erin Harris to unpack what today’s CGT leaders need to know about raw, starting, and ancillary materials. They explored evolving expectations around material selection, characterization, and sourcing; emerging guidance and standards from USP; how smarter analytics and vendor partnerships can reduce batch failures and CMC setbacks, and more.